Brace hinge with telescoping pad

ABSTRACT

A hinge which can be included on a brace is disclosed. The hinge can include a first arm, a second arm, and a hinge plate. The first and second arms can be connected to the hinge plate for rotation about first and second axes, respectively. The hinge plate can include an internally threaded aperture. The hinge can also include a force application assembly and an adjustment assembly. The adjustment assembly can include an externally threaded lead screw engaged with the internally threaded aperture, and having a medial end connected to the force application assembly and a keyed bore. The adjustment assembly can include a drive key having a keyed shaft slidingly engaged with the keyed bore and a knob connected to the drive key such that rotation of the knob causes displacement of the force application assembly.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/629,448, filed Jun. 21, 2017, which claims the benefit of U.S.Provisional No. 62/354,553, filed Jun. 24, 2016, and each of thesedisclosures is incorporated herein by reference in its entirety and forall purposes. U.S. application Ser. No. 10/074,520, filed Feb. 11, 2002,which issued as U.S. Pat. No. 6,752,775 on Jun. 22, 2004, and is alsoincorporated herein by reference in its entirety and for all purposes.Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

The present invention relates to braces, such as orthopedic braces. Moreparticularly, the present application describes a brace with a hingehaving a pad that is adjustable to apply pressure toward and/or awayfrom a joint. In some embodiments, the brace is a knee brace configuredfor treatment of osteoarthritis.

Osteoarthritis is a degenerative disease that can destabilize a kneejoint. The disease commonly results from aging, joint overuse, orinjury. A person afflicted with osteoarthritis may suffer chronic painwhen his or her knee joint is statically or dynamically loaded that maybe caused by an unbalanced loading on the joint. The unbalanced loadingoften collapses a compartment between the condyles of the femur andtibia, causing the condyles to contact each another. The contactingcondyles may develop painful abrasions.

SUMMARY

In a first aspect, a hinge is disclosed. The hinge includes a first arm,a second arm, and a hinge plate. The first arm is connected to the hingeplate for rotation about a first axis and the second arm is connected tothe hinge plate for rotation about a second axis. The hinge plateincludes an internally threaded aperture. The hinge also includes aforce application assembly and an adjustment assembly. The adjustmentassembly includes an externally threaded lead screw engaged with theinternally threaded aperture of the hinge plate. The lead screw includesa medial end connected to the force application assembly and a keyedbore extending along a longitudinal axis of the lead screw from alateral end of the lead screw toward the medial end. The adjustmentassembly also includes a drive key having a keyed shaft slidinglyengaged with the keyed bore and a knob connected to a lateral end of thedrive key such that rotation of the knob causes lateral or medialdisplacement of the force application assembly. The hinge may be used ina brace. The brace may be a knee brace. The hinge and the brace may beused for the treatment of osteoarthritis.

In some embodiments, the adjustment assembly further includes: a dialgear comprising a plurality of notches, and a tooth extending from theknob that engages with the plurality of notches during at least aportion of a full rotation of the knob such that rotation of the knobcauses rotation of the dial gear. In some embodiments, the adjustmentassembly further includes a pawl having a free end that engages with theplurality of notches of the dial gear. In some embodiments, the pawl isconfigured to prevent rotation of the dial gear when the tooth of theknob and the notches of the dial gear are not engaged. In someembodiments, the pawl comprises a C-shape that surrounds a portion ofthe dial gear. In some embodiments, the dial gear is configured to limitrotation of the knob. In some embodiments, the dial gear comprises amissing notch that limits rotation of the knob.

In some embodiments, the hinge further includes a plurality of positionindicators on the dial gear, one of the plurality of position indicatorsviewable through a window in a cover of the hinge depending on arotational position of the dial gear, the position indicators indicativeof the lateral or medial displacement of the force application assembly.In some embodiments, a distance between the knob and dial gear is fixed.In some embodiments, rotation of the knob causes lateral or medialdisplacement of the externally threaded lead screw through theinternally threaded aperture of the hinge plate. In some embodiments,the keyed bore of the lead screw comprises a D-bore shape and the keyedshaft of the drive key comprises a D-bore shape.

In some embodiments, the force application assembly includes a loadingplate connected to the medial end of the lead screw, and a condyleshell. In some embodiments, the hinge includes a spacer between theforce application assembly and the hinge plate. In some embodiments, thelead screw extends through an aperture in the spacer. In someembodiments, the spacer comprises foam. In some embodiments the hingeplate comprises a medial hinge plate, the hinge further including alateral hinge plate, the first and second arms positioned between thelateral hinge plate and the medial hinge plate, and a cover, wherein theknob and dial gear are positioned between the cover and the lateralhinge plate. In some embodiments, a boss extends from an interiorsurface of the cover, and wherein the dial gear is mounted on androtates around the boss. In some embodiments, the shaft of the drive keyextends through an aperture in the lateral hinge plate.

In a second aspect, a hinge for a brace is disclosed. The hinge includesa medial hinge plate including an internally threaded anterior aperturehaving an anterior axis extending therethrough and an internallythreaded posterior aperture having a posterior axis extendingtherethrough. The hinge includes a force application assembly. The hingeincludes an anterior adjustment assembly aligned along the anterior axisand a posterior adjustment assembly aligned along the posterior axis.Each of the anterior and posterior adjustment assemblies include anexternally threaded lead screw engaged with the internally threadedanterior aperture or the internally threaded posterior aperture of themedial hinge plate and having a medial end connected to the forceapplication assembly and a keyed bore extending along a longitudinalaxis of the lead screw from a lateral end of the lead screw toward themedial end. Each of the anterior and posterior adjustment assembliesinclude a drive key having a keyed shaft slidingly engaged with thekeyed bore and a knob connected to a lateral end of the drive key suchthat rotation of the knob causes lateral or medial displacement of theforce application assembly.

In some embodiments, the anterior adjustment assembly and the posterioradjustment assembly are independently adjustable. In some embodiments,the internally threaded anterior aperture and the internally threadedposterior aperture are aligned along a central transverse axis of themedial hinge plate.

In some embodiments, the hinge further includes an anterior adjustmentindicator assembly associated with the anterior adjustment assembly anda posterior adjustment indicator assembly associated with the posterioradjustment assembly. In some embodiments, each of the anterioradjustment indicator assembly and the posterior adjustment indicatorassembly include a dial gear comprising a plurality of notches, and atooth extending from the knob that engages with the plurality of notchesduring at least a portion of a full rotation of the knob such thatrotation of the knob causes rotation of the dial gear. In someembodiments, the adjustment assembly further includes a pawl having afree end that engages with the plurality of notches of the dial gear. Insome embodiments, the pawl is configured to prevent rotation of the dialgear when the tooth of the knob and the notches of the dial gear are notengaged.

In some embodiments, the hinge includes a cover. The cover may include acircular anterior boss extending from an interior surface of the coverand a circular posterior boss extending from an interior surface of thecover. The dial gears may be mounted on and rotate around the bosses. Insome embodiments, the anterior axis extends through the anterior bossand the posterior axis extends through the posterior boss. In someembodiments, the anterior boss is offset from a center longitudinal axisof the cover toward an anterior side of the hinge and the posterior bossis offset from the center longitudinal axis of the cover toward aposterior side of the hinge.

These and other aspects of the disclosure will become apparent from thefollowing detailed description, drawings, and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the brace and hinge described herein willbecome more fully apparent from the following description and appendedclaims, taken in conjunction with the accompanying drawings. Thesedrawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting of its scope. In thedrawings, similar reference numbers or symbols typically identifysimilar components, unless context dictates otherwise. In someinstances, the drawings may not be drawn to scale.

FIG. 1A shows an anterior view of one embodiment of a brace including ahinge with a telescoping force application assembly.

FIGS. 1B and 1C show lateral and medial views of an embodiment of abrace frame of the brace of FIG. 1A.

FIGS. 1D and 1E show outside and inside views of an embodiment to acover of the brace of FIG. 1A.

FIGS. 2A and 2B are perspective and lateral side views, respectively, ofthe hinge of FIG. 1A.

FIG. 3A shows an anterior view of the hinge of FIG. 2A with the forceapplication assembly in a first position.

FIG. 3B is an anterior view of the hinge of FIG. 2A in a secondconfiguration with the force application assembly extended in amedial/lateral direction.

FIG. 4A shows a top view of the hinge of FIG. 2A with the forceapplication assembly in the first position.

FIG. 4B is a top view of the hinge of FIG. 2A in the secondconfiguration with the force application assembly extended in themedial/lateral direction.

FIGS. 5A and 5B are lateral and medial partially exploded perspectiveviews, respectively, of the hinge of FIG. 2A.

FIG. 6 is an exploded perspective view of an embodiment of a hingeassembly for the hinge of FIG. 2A.

FIG. 7 shows a perspective view of the medial side of a hinge plate ofthe hinge of FIG. 2A.

FIG. 8A is a partially exploded perspective view of an embodiment of anadjustment assembly for the hinge of FIG. 2A.

FIG. 8B is a medial view of some of the components of the adjustmentassembly of FIG. 8A positioned within a cover of the hinge.

FIG. 8C is a lateral view of some of the components of the adjustmentassembly of FIG. 8A with the cover removed.

FIGS. 9A and 9B show medial perspective and medial views, respectively,of an embodiment of a cover for the hinge of FIG. 2A.

FIG. 10 shows a lateral partially exploded view of an embodiment of theforce application assembly for the hinge of FIG. 2A.

FIGS. 11A and 11B show lateral and medial exploded perspective views,respectively, of some of the components of the adjustment assembly ofFIG. 8A.

FIG. 12 shows a perspective view of an embodiment of a drive key and anadjustment screw.

FIGS. 13A and 13B shows lateral and medial partially explodedperspective views, respectively, of the hinge of FIG. 2A.

FIG. 14 is a cross-sectional view of the hinge taken along the line14-14 shown in FIG. 2B.

FIG. 15 is a cross-sectional view of the hinge taken along the line15-15 shown in FIG. 2B.

DETAILED DESCRIPTION

The following discussion presents detailed descriptions of the severalembodiments of a brace and brace hinge with a telescoping forceapplication as shown in the figures. These embodiments are not intendedto be limiting, and modifications, variations, combinations, etc., arepossible and within the scope of this disclosure.

FIG. 1A shows an anterior view of one embodiment of a brace 10 includinga hinge 100 with a telescoping force application assembly (thetelescoping force assembly 400 is shown, for example, in FIG. 2A). Thebrace 10 can be used for the treatment of osteoarthritis of a knee. Insome embodiments, the brace 10 is worn on the affected leg and isconfigured to apply a lateral/medial force to a lateral or medial sideof the knee in order to unload the affected compartment of the kneejoint and eliminate contact between the femur and tibia. In someembodiments, the force is applied to the knee at a point about 10° to15° posterior of the normal axis of rotation of the knee, although otherlocations for the application of the force are possible.

In the illustrated embodiment, the hinge 100 is positioned on thelateral side of the brace 10 and is configured to provide alateral/medial force to a lateral (outside) portion of a user's knee.Thus, the illustrated brace 10 is configured for use on a user's rightleg, although the brace may be configured in a mirrored configurationfor use on a user's left leg. Additionally, the brace 10 may beconfigured to provide a lateral/medial force to a medial (inside)portion of a user's knee. Accordingly, in some embodiments, the hinge100 may be positioned on the medial side of the brace 10. In someembodiments, the brace 10 may be configured to apply a force on both thelateral and medial portions of a user's knee by, for example, includinga hinge 100 on both the lateral and medial sides of the brace 10.Finally, while the illustrated brace 10 is configured to providetreatment for a knee joint, the brace 10 may be modified for use onother joints, such as, for example, elbows, ankles, or others.

The hinge 100 will be described below in detail in reference to FIGS.2A-15 . For ease of description, the hinge 100 illustrated in thefigures will be described below as configured for use on a lateral sideof a right knee. Those of skill in the art, however, will appreciate thehinge 100 may be adapted for use on the left side of a right knee, theright or left sides of a left knee, or on other joints in the body.While described as configured for use on a lateral side of a right knee,this application is not intended to be limited to only the describedapplication.

In the illustrated embodiment, the brace 10 includes a cover 20. Thecover 20 may be configured to wrap around a user's leg. The hinge 100may extend through an opening 23 in the cover 20. As illustrated, thecover 20 also includes a proximal opening 22 a and a distal opening 22b. When the brace 10 is worn, the leg extends through the cover 20 fromthe proximal opening 22 a to the distal opening 22 b. The cover 20 alsoincludes an anterior opening 25. The anterior opening 25 may be centeredover the user's knee when the brace 10 is worn. In some embodiments, thecover 20 also includes a posterior opening. The cover 20 may be securedto the leg with one or more fasteners. For example, in the illustratedembodiment, the cover 20 includes proximal and distal fasteners 26 a, 26b that close the cover 20 around the leg. The proximal and distalfasteners 26 a, 26 b may be hook and loop fasteners, as illustrated, orany other type of fastener including ties, buttons, zippers, toggles,etc. In the illustrated embodiment, proximal and distal tighteningstraps 34 a, 34 b extend through the cover 20. The proximal and distaltightening straps 34 a, 24 b may be connected to a brace frame 30 (asshown in FIGS. 1B and 1C). The proximal and distal tightening straps 34a, 34 b may be configured to allow the brace 10 to be tightened aroundthe leg. The proximal and distal tightening straps 34 a, 34 b may besecured with hook and loop fasteners, as illustrated, or any other typeof fastener. In some embodiments, the cover 20 is made from fabric oranother flexible material. The cover 20 may fit around the brace frame30 (shown in FIGS. 1B and 1C), which provides structural support for thebrace 10.

FIGS. 1B and 1C show lateral and medial views of an embodiment of abrace frame 30 of the brace 10 of FIG. 1A. As shown, the brace frame 30includes a proximal leg support 32 a and a distal leg support 32 b. Theproximal leg support 32 a is configured to be secured to a user's upperleg above the knee. In some embodiments, the proximal leg support 32 ais a rigid, semi-rigid, or flexible plate shaped to fit to a user'supper leg or thigh. In some embodiments, the proximal leg support 32 awraps around an anterior portion of the user's leg. In some embodiments,the proximal leg support 32 a wraps entirely around the user's leg. Theproximal tightening strap 34 a may be attached to the proximal legsupport 32 a to secure the proximal leg support 32 a to the leg.Similarly, the distal leg support 32 b is configured to be secured to auser's lower leg below the knee. In some embodiments, the distal legsupport 32 b is a rigid, semi-rigid, or flexible plate shaped to fit toa user's lower leg or calf. In some embodiments, the distal leg support32 b wraps around a posterior portion of the user's leg. In someembodiments, the distal leg support 32 b wraps entirely around theuser's leg. The distal tightening strap 34 b may be attached to thedistal leg support 32 b to secure the proximal leg support 32 b to theleg. The proximal leg support 32 a is attached to the hinge 100 by aproximal arm 140 a and the distal leg support 32 b is attached to thehinge 100 by a distal arm 140 b.

FIGS. 1D and 1E show outside and inside views of an embodiment to acover 20 of the brace 10 of FIG. 1A (illustrated removed from the braceframe 30 of the brace 10). In the illustrated embodiment, the opening 23for the hinge 100 is visible as well as several proximal and distalslits 27 a, 27 b configured to allow the proximal and distal tighteningstraps 34 a, 34 b to extend therethrough. As shown in the inside view ofFIG. 1E, the cover 20 can include a proximal pocket 28 a and a distalpocket 28 b configured to receive the proximal and distal leg supports32 a, 32 b. Other configurations for the cover 20 and the brace frame 30are possible.

FIGS. 2A and 2B are perspective and lateral side views, respectively, ofthe hinge 100 of FIG. 1 . As will become more fully apparent from thefollowing description, the hinge 100 may be configured to apply alateral/medial force to a user's knee and/or to allow, limit, orprohibit extension and flexion of the knee. In the illustratedembodiment, the hinge 100 includes a proximal arm 140 a and a distal arm140 b. Only the portions of the proximal and distal arms 140 a, 140 bthat are attached to the hinge 100 are illustrated. However, theopposite ends of the proximal and distal arms 140 a, 140 b (not shown inthe figures) can be connected to other components of the brace 10 and/orsecured to a user's leg. For example, in some embodiments, the proximalarm 140 a extends proximally from the hinge 100 and is connected to aproximal portion of the brace 10 that is secured above the knee on auser's thigh. Similarly, in some embodiments, the distal arm 140 bextends distally from the hinge 100 and is connected to a distal portionof the brace 10 that is secured below the knee on a user's lower leg.

In some embodiments, the proximal and distal arms 140 a, 140 b arepivotally connected to the hinge 100 (as will be described below ingreater detail with reference to FIG. 6 ). For example, the proximal anddistal arms 140 a, 140 b can be configured to rotate with respect to thehinge 100 or with respect to each other in response to the flexionand/or extension of the knee. In some embodiments, the proximal anddistal arms 140 a, 140 b are configured to rotate independently. In someembodiments, the proximal and distal arms 140 a, 140 b are configured torotate together. For example, rotation of the proximal arm 140 a may beconfigured to cause a corresponding and equal rotation of the distal arm140 b, or vice versa. In some embodiments, the rotation of the proximaland distal arms 140 a, 140 b lies in a single plane, although this neednot be the case in all embodiments. In some embodiments, the hinge 100may be bicentric. That is, the hinge 100 may comprise two axes ofrotation, one for each of the proximal and distal arms 140 a, 140 b. Thetwo axes may be spaced apart to produce a hinge rotation thatapproximates the bending dynamics of the human knee. In someembodiments, the hinge 100 may be monocentric. That is, the proximal anddistal arms 140 a, 140 b may share a common axis of rotation.

In some embodiments, the proximal and distal arms 140 a, 140 b can belocked in place, such that they do not rotate. In some embodiments, thehinge 100 can be configured such that the rotation of the proximal anddistal arms 140 a. 140 b can be limited. In this way, the brace 10 canbe configured to provide a limited range of motion.

The hinge 100 also includes a force application assembly 400. The forceapplication assembly 400 is configured to apply a lateral/medial forceto a user's knee. As will be described in greater detail below, theforce application assembly 400 can be displaced in a lateral/medialdirection to apply the lateral/medial force. In some embodiments, thebrace and hinge 100 are configured such that the force applicationassembly 400 is positioned over a lateral or medial side of a user'sknee when the brace is worn. Thus, the force application assembly 400can be configured to apply the lateral/medial force to the lateral ormedial side of a user's knee.

The hinge 100 is configured such that the force applied by the forceapplication assembly 400 can be adjusted. In the illustrated embodiment,the hinge 100 includes an anterior actuator or knob 230 a and aposterior actuator or knob 230 b. The anterior and posterior knobs 230a, 230 b may be manipulated, operated, or adjusted to control thedisplacement of the force application assembly 400. In the illustratedembodiment, the anterior knob 230 a extends out an anterior knob opening116 a in a cover 110 of the hinge 100 and the posterior knob 230 bextends out a posterior knob opening 116 b in the cover 110. While ananterior and a posterior knob 230 a, 230 b are illustrated in thefigures and described throughout this application, in some embodiments,the hinge 100 may be configured with the knobs (or other actuators) inother positions. For example, both knobs could be positioned on theanterior side or the posterior side of the hinge, or, as anotherexample, the knobs could extend out a lateral surface of the cover 110.Further, while two knobs are illustrated and described, in someembodiments, the hinge 100 may include only a single knob or more thantwo knobs.

In the illustrated embodiment, the cover 110 includes windows 112through which position indicators 222 are visible. As the anterior andposterior knobs 230 a, 230 b are adjusted the position indicators 222visible through the windows 112 are changed to indicate the displacementof the force application assembly 400. In the illustrated embodiment,the position indicators 222 are numerical values, although otherindicators, for example, colors, symbols, etc. are possible. In someembodiments, the windows 112 are configured as two apertures on oppositecorners of the lateral surface of the cover 110, although other numbersof windows 112 and/or other placements of the windows 112 on the hinge100 are possible. The cover 110 may also include additional indicatorsor markings 113 that can indicate the effect of rotation of the anterioror posterior knobs 230 a, 230 b in either the clockwise orcounterclockwise directions. For example, as illustrated, the cover 110includes “plus” and “minus” markings 113 indicating that rotation of theanterior or posterior knobs 230 a, 230 b in either the clockwise orcounterclockwise directions will cause positive and negativedisplacement, respectively, of the force application assembly 400.

Example displacement of the force application assembly 400 will bedescribed below in reference to FIGS. 3A through 4B. FIGS. 3A and 4Ashow anterior and top views of the hinge 100 with the force application400 assembly in a first position. In the illustrated first position, theforce application assembly 400 is positioned against a medial hingeplate 350 of the hinge 100. The first position may represent a retractedpositon or a position of approximately zero displacement. The firstposition may also represent application of a lower lateral/medial forceas compared with a second position shown in FIGS. 3B and 4B, which mayrepresent application of a higher lateral/medial force as compared withthe first position. In some embodiments, the force application assembly400 may apply approximately zero force to the knee in the firstposition.

FIGS. 3B and 4B show anterior and top views, respectively, of the hinge100 with the force application 400 in a second configuration. The secondconfiguration may represent an extended or displaced position relativeto the medial hinge plate 350. In the second configuration, the forceapplication assembly 400 has been displaced (in other words, extended)in a medial/lateral direction. In some embodiments the displacement isat predetermined displacement increment (e.g., 1 mm, 1.5 mm, 2 mm, 3 mmor any other predetermined increment). In some embodiments thedisplacement can be set to be any value between the least displacementand the greatest displacement that the force application assembly 400can be positioned (for example, configured for a non-incrementaldisplacement). In some embodiments, the force application assembly 400can be displaced at positions from between about 0 mm and about 50 mm.In some embodiments, the maximum displacement of the force applicationassembly 400 (measured relative to the medial hinge plate 350) isapproximately 30 mm, approximately 20 mm, or approximately 10 mm. Theforce application assembly 400 can be transitioned between the firstposition and the second position (and any position in between) bymanipulation of the anterior and posterior knobs 230 a, 230 b. As willbe described in greater detail below, displacement of the forceapplication assembly 400 can be caused by the telescoping or extensionof anterior and posterior lead screws 410 a, 410 b through the medialhinge plate 350. The anterior and posterior knobs 230 a, 230 b can beoperatively connected to the lead screws 410 a, 410 b. In the anteriorview of FIG. 3B, only the anterior lead screw 410 a is visible as theposterior lead screw 410 b is located behind the anterior lead screw 410a. FIG. 4B illustrates both the anterior lead screw 410 a and theposterior lead screw 410 b.

In some embodiments, the anterior and posterior lead screws 410 a, 410 bare independently adjustable, for example, via independent manipulationof the anterior and posterior knobs 230 a, 230 b. In the illustratedembodiments of FIGS. 3B and 4B, the anterior and posterior lead screws410 a, 410 b have been adjusted evenly (that is, with equal amounts ofextension through the medial hinge plate 350) such that the forceapplication assembly 400 is displaced an equal anterior and posterioramount. Although not illustrated, the anterior and posterior lead screws410 a, 410 b can be adjusted to provide an uneven force via the forceapplication assembly 400. For example, if the anterior lead screw 410 ais adjusted to provide a greater displacement than the posterior leadscrew 410 b, the force application assembly 400 will be positioned at anangle with respect to the medial hinge plate 350 and will apply agreater anterior force and a smaller posterior force. As anotherexample, if the anterior lead screw 410 a is adjusted to provide asmaller displacement than the posterior lead screw 410 b, the forceapplication assembly 400 will be positioned at an angle with respect tothe medial hinge plate 350 such that a smaller anterior force and agreater posterior force is applied. Thus, in some embodiments, the hinge100 is configured for independent adjustment of the force applicationassembly 400, allowing a user to apply varying and differing pressure tothe anterior and posterior portions of the knee.

Further, while the illustrated embodiment includes an anterior and aposterior lead screw 410 a, 410 b, other arrangements are possible. Forexample, the hinge 100 can include a proximal and a distal lead screwallowing for independent adjustment in a proximal/distal direction. Insome embodiments, the hinge 100 can include a single lead screw.

FIGS. 5A and 5B are lateral and medial partially exploded perspectiveviews, respectively, of the hinge 100 and will be describedconcurrently. In the illustrated embodiment, the hinge 100 includes ahinge mechanism assembly 300, the force application assembly 400, anadjustment assembly 200, and the cover 110. Not all of these componentsare necessary in all embodiments of the hinge 100.

In the illustrated embodiment, the hinge mechanism assembly 300 includesa lateral hinge plate 310 and a medial hinge plate 350. End portions ofthe proximal and distal arms 140 a, 140 b are received between thelateral and medial hinge plates 310, 350. In some embodiments, the hingemechanism assembly 300 is configured to allow the proximal and distalarms 140 a, 140 b to rotate as described above. The hinge mechanismassembly 300 will be described in detail below in reference to FIGS. 6and 7 .

The hinge 100 also includes the force application assembly 400. In theillustrated embodiment of FIGS. 5A and 5B, the force applicationassembly 400 includes a loading plate 420 and a condyle shell 430, aswell as the anterior and posterior loading screws 410 a, 410 b. Theforce application assembly 400 is positioned below (in other words, onthe medial side of) the medial hinge plate 350. The force applicationassembly 400 can include a foam (or other cushioning material) pad 405positioned between the medial hinge plate 350 and the loading plate 420as illustrated. As discussed previously, the force application assembly400 is configured for lateral/medial displacement relative to the medialhinge plate 350. In some embodiments, one or more of these componentsmay be omitted. The force application assembly 400 is described indetail below in reference to FIG. 10 .

The hinge also includes an adjustment assembly 200. In the illustratedembodiment of FIGS. 5A and 5B, the adjustment assembly 200 includes ananterior drive key 210 a, the anterior knob 230 a, an anterior dial gear220 a, and an anterior pawl 240 a that are configured to allowdisplacement of the anterior lead screw 410 a through the medial hingeplate 350 to control lateral/medial displacement of an anterior portionof the force adjustment assembly 400. The adjustment assembly 200 alsoincludes a posterior drive key 210 b, the posterior knob 230 b, aposterior dial gear 220 b, and a posterior pawl 240 b that areconfigured to allow displacement of the anterior lead screw 410 athrough the medial hinge plate 350 to control lateral/medialdisplacement of a posterior portion of the force adjustment assembly400. The adjustment assembly is positioned between the lateral hingeplate 310 and the cover 110. Again, not all of these components arenecessary in all embodiments of the hinge 100. The adjustment assembly200 and cover 110 will be described in detail in reference to FIGS.8A-9B.

FIG. 6 is an exploded view of one embodiment of the hinge mechanismassembly 300. In the illustrated embodiment, the hinge mechanismassembly 300 includes the lateral hinge plate 310 and the medial hingeplate 350. FIG. 7 shows the medial face of the medial hinge plate 350.As illustrated, each of the lateral and medial hinge plates 310, 350 isa flat bracket or plate and is substantially oval shaped, although othershapes are possible. In some embodiments, the profile shape of each ofthe lateral and medial hinge plates 310, 350 is the same. Each of thelateral and medial hinge plates 310, 350 can be between approximately0.05 mm and 1 cm mm thick, although other thicknesses are possible. Insome embodiments, the medial hinge plate 350 is thicker than the lateralhinge plate 310, although, in some embodiments, the medial hinge plate350 and the lateral hinge plate 310 can have the same thickness or thelateral hinge plate 310 can be thicker than the medial hinge plate.

As illustrated, for some embodiments, each of the lateral and medialhinge plates 310, 350 includes a plurality apertures extending therethrough. In some embodiments, one or more of the apertures of thelateral hinge plate 310 are aligned with the one or more apertures ofthe medial hinge plate 350. In some embodiments, apertures are alignedalong four distinct axes of the hinge mechanism assembly 300. Forexample, apertures can be aligned along a proximal arm rotation axis 2a, a distal arm rotation axis 2 b, an anterior adjustment axis 4 a, anda posterior adjustment axis 4 b. In some embodiments, the proximal anddistal arms 140 a, 140 b are configured to rotate around the proximaland distal arm rotation axes 2 a, 2 b. In some embodiments, displacementof the anterior and posterior lead screws 410 a, 410 b occurs along theanterior and posterior adjustment axes 4 a, 4 b, respectively.

The medial hinge plate 350 includes a proximal aperture 352 a and distalaperture 352 b. In some embodiments, the proximal and distal aperturesare aligned along a central longitudinal axis of the medial hinge plate350. In some embodiments, the proximal aperture 352 a is locatedsubstantially in the center of a proximal half of the medial hinge plate350, and the distal aperture 352 b is located substantially in thecenter of a distal half of the medial hinge plate 350. The medial hingeplate 350 also includes an anterior aperture 354 a and posterioraperture 354 b. In some embodiments, the anterior aperture 354 a and theposterior apertures 354 b can be aligned along a central transverse axisof the medial hinge plate 350. In some embodiments, the anterioraperture 354 a is located near a center of an anterior edge of themedial hinge plate 350, and each posterior aperture 354 b is locatednear a center of a posterior edge of the medial hinge plate 350. Theanterior and posterior apertures 354 a, 354 b can be internallythreaded. As will be described below, in some embodiments, the internalthreads of the anterior and posterior apertures 354 a, 354 b engage withexternal threads of the lead screws 410 a, 410.

In the illustrated embodiment, the medial hinge plate 350 includesapertures 358. The apertures 358 are positioned near the anterior andposterior sides of the medial hinge plate and surround the anterior andposterior apertures 354 a, 354 b. In some embodiments, the additionalapertures 358 are smaller than the anterior and posterior apertures 354a, 354 b and/or the proximal and distal apertures 352 a, 352 b. Whileadditional anterior and posterior apertures 358 are illustrated in thefigures and described throughout this application, in some embodiments,the hinge mechanism assembly 300 may be configured without theseapertures or with additional apertures in other positions. As shown inthe FIG. 7 , the medial face of the medial hinge plate 350 includesanterior and posterior bosses 356 a, 356 b surrounding the anterior andposterior apertures 354 a, 354 b. The anterior and posterior bosses 356a, 356 b may extend the internally threaded length of the anterior andposterior apertures 354 a, 354 b. The anterior and posterior bosses 356a, 356 b may also serve as a contact point for the force applicationassembly 400. In other words, in some embodiments, the force applicationassembly 400 can be retracted until it contacts the bosses 356 a, 356 b.

The lateral hinge plate 310 may include a plurality of apertures thatcorrespond to the apertures of the medial hinge plate 350 describedabove. For example, in the illustrated embodiment, the lateral hingeplate includes a proximal aperture 312 a, a distal aperture 312 b, ananterior apertures 314 a, and a posterior aperture 314 b. In someembodiments, the anterior and posterior apertures 314 a, 314 b are notthreaded. The lateral hinge plate 310 also includes additional apertures316.

The anterior apertures 354 a of the lateral and medial hinge plates 310,350 are aligned along the anterior adjustment axis 4 a. The posteriorapertures 354 b of the lateral hinge plates are aligned along theposterior adjustment axis 4 b. While an anterior and posterior aperture354 a, 354 b are illustrated in the figures and described throughoutthis application, in some embodiments, the hinge mechanism assembly 300may be configured with the apertures in other positions. For example,both apertures could be located toward one side of the hinge plates orbe spaced from a proximal/distal axis of the hinge plates. The anteriorand posterior apertures 354 a, 354 b may include internal threads thatcooperate with an anterior lead screw 410 a and posterior lead screw 410b (not shown), respectively, to adjust an amount of pressure exerted ona lateral side of a user's knee.

The lateral and medial hinge plates 310, 350 may be made from metal,plastic, or other suitable materials. In some embodiments, the lateraland medial hinge plates 310, 350 are substantially rigid. In someembodiments, the lateral and medial hinge plates 310, 350 are flexible.In some embodiments, one of the lateral or medial hinge plates 310, 350can be omitted.

The proximal and distal arms 140 a, 140 b are positioned between thelateral and medial hinge plates 310, 350. In some embodiments, theproximal arm 140 a is formed from a substantially flat plate. The platemay be, for example, between approximately 0.5 mm and 2 cm thick,although other thicknesses are possible. The proximal arm 140 a caninclude a hinge-engaging portion 142 a at a posterior end, which has acomplex perimeter, including an anterior shoulder 148 a, a posteriorshoulder 146 a, and a plurality of gear teeth 145 along distal andposterior edges. The proximal arm 140 a includes pivot aperture 144 anear the proximal end. The distal arm 140 b is substantially identicalto the proximal arm 140 a, but is a substantial mirror of the proximalarm 140 a about an axis that passes through a center of the hinge 100 inan anterior/posterior direction. The proximal and distal arms 140 a, 140b rotate around the proximal and distal arm rotation axes 2 a, 2 b aboutthe respective pivot apertures 144 a, 144 b, such that the plurality ofteeth gear of both arms engage each other. This causes rotation of onearm to be transferred to the other arm. In some embodiments, there is alimited plurality (i.e., a limited number) of gear teeth 144 between theanterior and posterior shoulders 148 b, 146 b of the proximal and distalarms 140 a, 140 b to limit the range of motion of brace 10. In anotherembodiment, the plurality of gear teeth of both arms may be configuredto rotate together, at equal angles from an axis in the distal/proximaldirection. In other embodiments, the proximal and distal arms 140 a, 140b can be locked in place, such that they do not rotate. The proximal anddistal arms 140 a, 140 b can be made from a metal, plastic, or othersuitable materials. In some embodiments, the proximal and distal arms140 a, 140 b are rigid. In some embodiments, the proximal and distalarms 140 a, 140 b are flexible.

In some embodiments, the hinge mechanism 300 can include a lateralplate, spacer, or washer 320 and a medial plate, spacer, or washer 340on each of the lateral and medial sides of the proximal and distal arms140 a, 140 b, for example as illustrated in FIG. 6 . The lateral andmedial washers 320, 340 can each be substantially similar to each other.The lateral washer 320 will now be described, but the description isalso applicable to the medial washer 340. The lateral washer 320 may beconfigured as a thin, flat plate. The lateral washer 320 can include aplurality of apertures aligned with one or more of the apertures of thelateral and/or medial hinge plates 310, 350. As illustrated the lateralwasher 320 includes a proximal aperture 344 a, a distal aperture 344 b,an anterior aperture 346 a, and a posterior aperture 356 b. In someembodiments, the lateral washer 320 may be constructed of a materialhaving a low coefficient of friction, such as plastic. The lateralwasher 320 thus enables the proximal and distal arms 140 a, 140 b torotate more easily within the hinge assembly 300. In some embodimentsone or both of the lateral and/or medial washers 320, 340 can beomitted.

The proximal apertures 312 a, 324 a, 144 a, 344 a, 352 a can be alignedalong the proximal arm rotation axis 2 a. The distal apertures 312 b,324 b, 144 b, 344 b, 352 b can be aligned along the distal arm rotationaxis 2 b. Proximal and distal fasteners, such as rivets 127 a, 127 b canbe used to secure the components of the hinge mechanism 300 as shown inthe cross-sectional view of FIG. 15 . The anterior apertures 314 a, 326a, 346 a, 354 a can be aligned along the anterior adjustment axis 4 a.The posterior apertures 314 b, 326 b, 346 b, 354 b can be aligned alongthe posterior adjustment axis 4 b.

FIG. 8A is an exploded view of the adjustment assembly 200 and the cover110. The hinge mechanism assembly 300 and the force application assembly400 are also shown in FIG. 8A in an assembled state positioned below theadjustment assembly 200. In the illustrated embodiment, the adjustmentassembly 200 includes the anterior drive key 210 a, the anterior knob230 a, the anterior dial gear 220 a, and the anterior pawl 240 a. Theadjustment assembly 200 also includes the posterior drive key 210 b, theposterior knob 230 b, the posterior dial gear 220 b, and the posteriorpawl 240 b.

The anterior drive key 210 a includes a keyed head 211 a and a keyedshaft 212 a. The keyed shaft 212 a can extend through an opening in theanterior knob 230 a. The keyed head 211 a can be received in acorresponding keyed recess 231 a in the anterior knob. In theillustrated embodiment, the keyed head 211 a and the keyed recess 231 aeach comprise a square shape, although other shapes are possible. Thekeyed head 211 a and the keyed recess 231 a are configured such thatwhen the keyed head 211 a is received in the keyed recess 231 a,rotation of the anterior knob 230 a causes equal and correspondingrotation of the anterior drive key 210 a. In other words, whenassembled, the anterior knob 230 a and the anterior drive key 210 arotate together. In some embodiments, the anterior knob 230 a and theanterior drive key 211 a may be formed as a unitary part.

The keyed shaft 212 a of the anterior drive key 210 a extends throughthe anterior knob 230 a and into a keyed bore 412 a of the anterior leadscrew 410 a. In the illustrated embodiment, the keyed shaft 212 acomprises a D-bore shaft shape and the keyed bore comprises acorresponding D-bore shape, although other keyed shapes are possible.The keyed shaft 212 a and the keyed bore 412 a are configured totransfer rotation between the anterior drive key 210 a and the anteriorlead screw 410 a. That is, the anterior drive key 210 a and the anteriorlead screw 410 a rotate together. As will be described below, rotationof the anterior knob 230 a is transmitted to the anterior lead screw 410a by the anterior drive key 210 a causing lateral/medial displacement ofan anterior portion of the force application assembly 400. The anteriordrive key 211 a, anterior knob 230 a, and the anterior lead screw 410 aare aligned along the anterior adjustment axis 4 a.

As illustrated, in some embodiments, the anterior dial gear 220 a andthe anterior pawl 240 a are associated with the anterior drive key 210a, anterior knob 230 a, and the anterior lead screw 410 a. As describedherein, the anterior dial gear 220 a can include position indicators 222that are visible through a window 112 in the cover 110 to indicate theamount of displacement of the force application assembly 400. As will bedescribed below, rotation of the anterior knob 230 a may cause rotationof the anterior dial gear 220 a, causing a different position indicator222 to be visible. In some embodiments, the rotation of the anteriordial gear 220 a is less than the rotation of the anterior knob 230 a.For example, in some embodiments, a full rotation of the anterior knob230 a causes a partial rotation of the anterior dial gear 220 a thatcorresponds to a change of one position indicator 222 on the anteriordial gear 220 a. The anterior pawl 240 a is engaged with the anteriordial gear 220 a to limit or prevent inadvertent or unintentionalrotation of the anterior dial gear 220 a.

The posterior drive key 210 b, posterior knob 230 b, and posterior leadscrew 410 b are similarly configured to the corresponding anteriorcomponents described above, but are aligned along the posterioradjustment axis 4 b. The posterior dial gear 220 b and the posteriorpawl 240 b are associated with the posterior drive key 210 b, posteriorknob 230 b, and posterior lead screw 410 b and are similar to thecorresponding anterior components described above.

The interplay and arrangement of the components of the adjustmentassembly 200 within the cover 110 will now be described with referenceto the embodiment of FIGS. 8B-9B. FIG. 8B is a medial view of some ofthe components of the adjustment assembly 200 positioned within a cover110. FIG. 8C is a lateral view of some of the components of theadjustment assembly 200 with the cover 110 removed. FIGS. 9A and 9B showmedial perspective and medial views, respectively, of an embodiment ofthe cover 110.

As shown in FIG. 8A, the anterior dial gear 220 a is a substantiallyannular gear having an internal aperture 221 a. The internal aperture221 a is aligned with a central axis of the anterior dial gear 220 a.The internal aperture 221 a is positioned on an anterior boss 121 a ofthe cover 110 (as seen in FIGS. 9A and 9B). In some embodiments, theanterior boss 121 a extends from an inner surface of the cover 110. Theanterior boss 121 a and internal aperture 221 a are configured such thatthe anterior dial gear 220 a can rotate around the anterior boss 121 a.In other words, the anterior dial gear 220 a is received on and rotatesaround the anterior boss 121 a of the cover 110.

The anterior dial gear 220 a also includes a plurality of notches 221spaced at even intervals around its perimeter. The notches areconfigured in size and shape to mesh with a tooth 235 a that is formedon the medial surface of the anterior knob 230 a during at least aportion of the rotation of the anterior knob 230 a. For example, in theillustrated embodiment, during each full rotation of the anterior knob230 a, the tooth 235 a engages with one of the notches 221 of theanterior dial gear 220 a and causes a partial rotation of the anteriordial gear 220 a that is equal to the distance between adjacent notches221. In FIG. 8B, the tooth 235 b of the posterior knob 230 b is shownengaged with a notch 221 of the posterior dial gear 220 b. In someembodiments, the anterior dial gear 240 a includes a missing notch 223(in other words, at one location around the perimeter of the dial gear240 a a notch is omitted or a spacing between two notches is larger(e.g., twice as large) as a spacing between the remaining notches). Themissing notch 223 may serve to limit rotation of the anterior knob 230a. For example, as described above, for each rotation of the anteriorknob 230 a the tooth 235 a advances the anterior dial gear 240 a onenotch. However, when the tooth 235 a reaches the missing notch 223, themissing notch 223 prevents the anterior knob 230 a from rotating furtherin that direction. The location of the missing notch 223 may bepositioned to represent a maximum and/or minimum lateral/medialdisplacement of the force application assembly 400.

As shown in FIGS. 8B, 9A, and 9B, the anterior boss 121 a of the cover110 is offset toward the anterior side of the cover 110 from the centrallongitudinal axis 6 of the cover 110. This offset allows the anteriordial gear 220 a to engage with the anterior knob 230 a withoutinterfering with the posterior knob 230 b. Similarly, the posterior boss121 b is offset toward the posterior side of the cover to allow theposterior 220 b to engage with the posterior knob 230 b withoutinterfering with the anterior knob 230 a.

The anterior pawl 240 a is configured to prevent rotation of theanterior dial gear 220 a when the tooth 235 a is not engaged with anynotch of the anterior dial gear 220 a. In FIG. 8B, the anterior knob 230a is illustrated in a rotational position where the tooth 235 a is notengaged with any notch 221 of the anterior dial gear. In the illustratedembodiment, the anterior pawl 240 a comprises a C-shape that partiallysurrounds the anterior dial gear 220 a. Free ends 242 of the anteriorpawl 240 a are engaged with notches 221 to prevent or limit rotation.The C-shape of the anterior pawl 240 a is configured to be flexible suchthat rotation of the dial gear 220 a caused by the anterior knob 230 acauses the free ends 242 to flex outward allowing the dial gear 220 a torotate. The anterior pawl 240 a includes an aperture 243 a that ismounted on a post 143 a that extends from the interior surface of thecover 110 as shown in FIGS. 9A and 9B. Other shapes for the anteriorpawl 240 a are possible.

As shown in FIG. 8B, the keyed shaft 210 a of the anterior drive key 210a extends through an opening in the anterior knob 230 a.

Turning now to the lateral view of FIG. 8C, the anterior dial gear 220 aand the anterior pawl 240 a rest substantially on top of the lateralhinge plate 310. Accordingly, in some embodiments, the anterior dialgear 220 a and the anterior pawl 240 a are sandwiched between thelateral hinge plate 310 and the interior surface of the cover 110. Theanterior dial gear 220 a can include the series of position indicators222 on the lateral surface thereof. As previously noted, the positionindicators 222 specify the displacement of the force applicationassembly 400 from the hinge 100. The illustrated embodiment showsnumbers one through twelve as the position indicators 222, but otherindicators may be used, such as, colors or symbols.

As shown in FIG. 8C, the keyed head 211 a of the anterior drive key 210is received within the keyed recess 231 a of the anterior knob 230 a. Insome embodiments, a portion of the anterior knob 230 a is configured torotate spaced laterally above the anterior dial gear 220 a. In someembodiments, the tooth 235 a of the anterior knob 230 a is located on amedial protrusion that extends from the medial side of the anterior knob230 a. In some embodiments, the medial protrusions rests and rotates onthe lateral hinge plate 310 and positions the tooth 235 a in the planeof the anterior dial gear 220 a and spaces the remainder of the anteriorknob 230 a above the anterior dial gear. As illustrated in FIGS. 9A and9B, in some embodiments, interior surface of the cover 110 may includean anterior recess 115 a. The anterior recess 115 a may be configured toreceive a portion of the anterior knob 230 a to secure the anterior knob230 a. For example, in some embodiments, a lateral surface of theanterior knob 230 a includes a shape that fits within the anteriorrecess 115 a of the cover 110.

Although the preceding description of FIGS. 8B-9C has discussed theanterior components of the adjustment assembly 200, the posteriorcomponents of the adjustment assembly 200 may be similarly configured.

Returning to FIG. 8A, as illustrated, the cover 110 can comprise covermarkings 113 on the anterior and posterior edges, two windows 112, aproximal and distal aperture 114 a, 114 b, and an anterior and posteriorknob opening 116 a, 116 b, although other arrangement and features forthe cover 110 are possible.

The hinge mechanism assembly 300, the adjustment assembly 200, and thecover 110 may be secured together using fasteners, such as rivets 127 a,127 b (see FIG. 8A and FIG. 15 ). The rivets 127 a, 127 b may extendalong the proximal and distal rotation axes 2 a, 2 b.

FIG. 10 shows a lateral partially exploded view of an embodiment of theforce application assembly 400. In the illustrated embodiment, the forceapplication assembly includes a foam pad 405, the anterior and posteriorlead screws 410 a, 410 b, a loading plate 420, and a condyle shell 430.

In some embodiments, the foam (or other cushioning material) pad 450 ispreferably made of foam or other suitable material for padding. The foampad 450 is the substantially similar to the oval and flat shape of themedial hinge plate 350. In some embodiments, the foam pad 450 may beapproximately 2 mm thick, although other thicknesses are possible. Thefoam pad 450 is positioned between the medial hinge plate 350 andloading plate 420. The foam pad 450 has an anterior and posterioraperture 405 a, 405 b corresponding to the anterior and posteriorapertures 352 a, 352 b of the lateral and medial hinge plates 310, 350.The anterior and posterior apertures 405 a, 405 b of the foam pad 450allow the threaded lateral ends 412 a, 412 b of the lead screws 410 a,410 b to extend there through.

In some embodiments, the loading plate 420 may be substantially ovalshaped and can include proximal and distal apertures 424 a, 424 bcorresponding to the proximal and distal apertures 352 a, 352 b of thehinge plates 310, 350. In the illustrated embodiment, the posterior andanterior edges of the loading plate 420 are curved in the lateraldirection. The loading plate 420 also can include anterior and posteriorslots 421 a, 421 b that are aligned with the anterior and posteriorapertures 405 a, 405 b of the foam pad 500 along the anterior andposterior adjustment axes 4 a, 4 b. The anterior and posterior slots 421a, 421 b may extend in the anterior/posterior direction and may belocated near the center of the loading plate 420 as measured in theproximal/distal direction. The anterior and posterior slots 421 a, 421 bcan include a narrow portion at the posterior end 423 b and a narrowportion at an anterior end 422 b. The loading plate 420 also includes ananterior slot 421 a is substantially identical to the posterior slot 421b, but is a mirror image of the posterior slot 421 b about a linebisecting the loading plate 420 in a proximal/distal direction. Theanterior slot 421 a receives a medial end 411 a of the anterior leadscrew 410 a. The posterior slot 421 b receives a medial end 411 b of theposterior lead screw 410 b.

In some embodiments, the condyle shell 430 is also substantially ovalshaped and includes proximal and distal apertures 424 a, 424 bcorresponding to the proximal and distal apertures of the loading plate.In the illustrated embodiment, the posterior and anterior edges arecurved in the posterior direction. A medial surface of the loading plate420 is secured to a lateral surface of the condyle shell 430. Theloading plate 420 is secured to the condyle shell 430 via a pair ofrivets 440 a, 440 b (see FIGS. 10 and 14 ) that cooperate with theproximal and distal apertures 424 a, 424 b on the loading plate 420 andcondyle shell 430. However, other suitable methods could be used tosecure the loading plate 420 and condyle shell 430.

FIGS. 11A and 11B show lateral and medial exploded perspective views ofthe components of the hinge 100 that allow for lateral/medialdisplacement of the force application assembly 100 according to oneembodiment. As discussed previously, rotation of the anterior knob 230 ais transmitted to the lead anterior lead screw 410 a by the anteriordrive key 410 a. The anterior lead screw 410 a is externally threadedand received in the internally threaded anterior aperture of the medialhinge plate 350. As the anterior lead screw 410 a rotates, the threadedengagement between the anterior lead screw 410 a and the medial hingeplate 310 causes the anterior lead screw 410 to telescope in and out(medially and laterally) relative to the medial hinge plate 350. Theanterior lead screw 410 a slides along the keyed shaft 212 a of theanterior drive key 210 a. The medial end of the anterior lead screw 410a is received in the anterior slot 421 a of the loading plate 420. Thus,as the anterior lead screw 410 a telescopes in and out, the anteriorportion of the loading plate 420 is displaced in a lateral/medialdirection. The posterior portion of the loading plate 420 is similarlydisplaceable by rotation of the posterior knob 430 b.

FIG. 12 shows a detailed perspective view of an embodiment of a drivekey 210 and a lead screw 410. As described above, the drive key 210includes a keyed head 211 and a keyed shaft 212. In the illustratedembodiment, the lead screw 410 includes an externally threaded portion413 and the keyed bore 412, which extends into a lateral end of the leadscrew 410. The medial end 419 of the lead screw 410 includes a firstcoaxial disk 414 having a diameter larger than that of the threadedportion 412. The medial end 419 also includes a second coaxial disk 415that is separated from the first coaxial disk 414 by a coaxialcylindrical portion 416 having a diameter substantially the same as thethreaded portion 413. A space between the two disks 414, 415 thusdefines an annular gap 417. The two disks 414, 415 and the annular gap417 are used to secure the medial end 419 of the lead screw 410 to theloading plate 420.

FIGS. 13A and 13B show lateral and medial partially exploded perspectiveviews, respectively, of the hinge 100 according to one embodiment. Asshown in FIGS. 13A and 13B, the gap 417 a of the anterior lead screw 410a engages the anterior slot 421 a on the loading plate 420, and the gap417 b on the posterior lead screw 410 b engages the posterior slot 421 bof the loading plate 420. The disks 414, 415 at the medial ends 419 ofthe lead screws 410 a, 410 b each have a smaller diameter than a widthof the wide portions of the anterior and posterior slots 421 a, 421 b.However, the disks 414, 415 each have a larger diameter than a width ofthe narrow portions of the anterior and posterior slots 423 a, 423 b.Further, the cylindrical portions 416 a, 416 b of each lead screw 410 a,410 b between the disks 414, 415 have smaller diameter than the width ofthe narrow portions 423 a, 423 b of the anterior and posterior slots 421a, 421 b. Thus, the anterior lead screw 410 a is insertable within thewide portion 422 a of the anterior slot 421 a and slidable into thenarrow portion 423 a of the anterior slot 421 a are disposed between thedisks 414, 415, such that there is a small amount of “play” between theloading plate 420 and the lead screws 410 a, 410 b. The posterior leadscrew 410 b is engageable with the posterior slot 421 b in the samemanner that the anterior lead screw 410 a is engageable with theanterior slot 421 a.

FIG. 14 is a cross-sectional view of the hinge taken along the line14-14 shown in FIG. 2B. FIG. 15 is a cross-sectional view of the hingetaken along the line 15-15 shown in FIG. 2B.

The foregoing description details certain embodiments of the systems,devices, and methods disclosed herein. It will be appreciated, however,that no matter how detailed the foregoing appears in text, the systems,devices, and methods can be practiced in many ways. As is also statedabove, it should be noted that the use of particular terminology whendescribing certain features or aspects of the invention should not betaken to imply that the terminology is being re-defined herein to berestricted to including any specific characteristics of the features oraspects of the technology with which that terminology is associated.

It will be appreciated by those skilled in the art that variousmodifications and changes may be made without departing from the scopeof the described technology. Such modifications and changes are intendedto fall within the scope of the embodiments. It will also be appreciatedby those of skill in the art that parts included in one embodiment areinterchangeable with other embodiments; one or more parts from adepicted embodiment can be included with other depicted embodiments inany combination. For example, any of the various components describedherein and/or depicted in the figures may be combined, interchanged orexcluded from other embodiments.

The above description discloses several methods and materials of thepresent invention. This invention is susceptible to modifications in themethods and materials, as well as alterations in the fabrication methodsand equipment. Such modifications will become apparent to those skilledin the art from a consideration of this disclosure or practice of theinvention disclosed herein. Consequently, it is not intended that thisinvention be limited to the specific embodiments disclosed herein, butthat it cover all modifications and alternatives coming within the truescope and spirit of the invention as embodied in the attached claims.Applicant reserves the right to submit claims directed to combinationsand sub-combinations of the disclosed inventions that are believed to benovel and non-obvious. Inventions embodied in other combinations andsub-combinations of features, functions, elements and/or properties maybe claimed through amendment of those claims or presentation of newclaims in the present application or in a related application. Suchamended or new claims, whether they are directed to the same inventionor a different invention and whether they are different, broader,narrower or equal in scope to the original claims, are to be consideredwithin the subject matter of the inventions described herein.

1.-13. (canceled)
 14. A hinge for a brace comprising: a medial hingeplate including an internally threaded anterior aperture having ananterior axis extending therethrough, and an internally threadedposterior aperture having a posterior axis extending therethrough; aforce application assembly; an anterior adjustment assembly alignedalong the anterior axis and a posterior adjustment assembly alignedalong the posterior axis, each including an externally threaded leadscrew engaged with the internally threaded anterior aperture or theinternally threaded posterior aperture of the medial hinge plate andhaving a medial end connected to the force application assembly, and akeyed bore extending along a longitudinal axis of the lead screw from alateral end of the lead screw toward the medial end, a drive key havinga keyed shaft slidingly engaged with the keyed bore, and a knobconnected to a lateral end of the drive key such that rotation of theknob causes lateral or medial displacement of the force applicationassembly.
 15. The hinge of claim 14, wherein the anterior adjustmentassembly and the posterior adjustment assembly are independentlyadjustable.
 16. The hinge of claim 14, wherein the internally threadedanterior aperture and the internally threaded posterior aperture arealigned along a central transverse axis of the medial hinge plate. 17.The hinge of claim 14, further comprising an anterior adjustmentindicator assembly associated with the anterior adjustment assembly anda posterior adjustment indicator assembly associated with the posterioradjustment assembly, each of the anterior adjustment indicator assemblyand the posterior adjustment indicator assembly comprising: a dial gearcomprising a plurality of notches; and a tooth extending from the knobthat engages with the plurality of notches during at least a portion ofa full rotation of the knob such that rotation of the knob causesrotation of the dial gear.
 18. The hinge of claim 17, further comprisinga cover including a circular anterior boss extending from an interiorsurface of the cover and a circular posterior boss extending from aninterior surface of the cover, and wherein the dial gears are mounted onand rotate around the bosses.
 19. The hinge of claim 18, wherein theanterior axis extends through the anterior boss and the posterior axisextends through the posterior boss.
 20. The hinge of claim 19, whereinthe anterior boss is offset from a center longitudinal axis of the covertoward an anterior side of the hinge and the posterior boss is offsetfrom the center longitudinal axis of the cover toward a posterior sideof the hinge.
 21. The hinge of claim 18, wherein the cover furthercomprises at least one window aligned such that a position indicator onthe dial gear is visible through the at least one window.
 22. The hingeof claim 14, further comprising a lateral hinge plate positioned betweenthe medial hinge plate and the anterior adjustment assembly and theposterior adjustment assembly, wherein the keyed shaft extends throughan aperture in the lateral hinge plate.
 23. The hinge of claim 22,wherein the aperture in the lateral hinge plate further comprises ananterior aperture aligned with the anterior axis and a posterioraperture aligned with the posterior axis.
 24. The hinge of claim 22,further comprising a first arm and a second arm, wherein the first armand the second arm are positioned between the medial hinge plate and thelateral hinge plate.
 25. The hinge of claim 24, wherein the first armfurther comprises a first pivot aperture and wherein the first armrotates around the pivot aperture.
 26. The hinge of claim 24, whereinthe second arm further comprises a second pivot aperture and wherein thesecond arm rotates around the second pivot aperture.
 27. The hinge ofclaim 24, wherein the first arm and the second arm engage with eachother through a plurality of gear teeth.
 28. The hinge of claim 14,wherein the keyed shaft and the keyed bore comprise a D-bore shape. 29.The hinge of claim 14, wherein the force application assembly furthercomprises a foam pad, wherein the foam pad comprises at least twoapertures.
 30. The hinge of claim 29, wherein each of the at least twoapertures of the foam pad align with each of the externally threadedlead screws.
 31. The hinge of claim 14, wherein the force applicationassembly further comprises a loading plate having a medial surface. 32.The hinge of claim 31, wherein the force application assembly furthercomprises a shell having a lateral surface, wherein the lateral surfaceof the shell is secured to the medial surface of the loading plate. 33.The hinge of claim 32, wherein the loading plate and the shell aresecured via a pair of rivets.